U.S. patent application number 10/563340 was filed with the patent office on 2007-05-10 for wound dresssing, ingredient delivery device and iv hold-down, and method relating to same.
Invention is credited to David R. Johnson, Steven R. Klemm, Michael G. Marcoux.
Application Number | 20070106195 10/563340 |
Document ID | / |
Family ID | 34084511 |
Filed Date | 2007-05-10 |
United States Patent
Application |
20070106195 |
Kind Code |
A1 |
Marcoux; Michael G. ; et
al. |
May 10, 2007 |
Wound dresssing, ingredient delivery device and iv hold-down, and
method relating to same
Abstract
An adhesive device used as a wound dressing, ingredient delivery
device or IV hold-down in which inadvertent edge release of these
devices along the periphery of the polymeric film layer is
minimized when the handling layer, which is adhered to the
polymeric film layer, is removed after application of the polymeric
film layer to the patient.
Inventors: |
Marcoux; Michael G.;
(Wyoming, MI) ; Johnson; David R.; (Granger,
IN) ; Klemm; Steven R.; (Grand Rapids, MI) |
Correspondence
Address: |
PRICE HENEVELD COOPER DEWITT & LITTON, LLP
695 KENMOOR, S.E.
P O BOX 2567
GRAND RAPIDS
MI
49501
US
|
Family ID: |
34084511 |
Appl. No.: |
10/563340 |
Filed: |
July 2, 2004 |
PCT Filed: |
July 2, 2004 |
PCT NO: |
PCT/US04/21521 |
371 Date: |
July 24, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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60484711 |
Jul 3, 2003 |
|
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60508088 |
Oct 2, 2003 |
|
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60570666 |
May 13, 2004 |
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Current U.S.
Class: |
602/57 |
Current CPC
Class: |
A61F 2013/00646
20130101; A61F 13/023 20130101; A61F 13/0203 20130101; A61F
2013/00821 20130101; A61F 2013/00834 20130101; A61F 2013/00812
20130101; A61F 2013/00327 20130101; A61F 2013/00761 20130101; A61F
2013/008 20130101 |
Class at
Publication: |
602/057 |
International
Class: |
A61F 15/00 20060101
A61F015/00 |
Claims
1. A wound dressing, ingredient delivery device or IV hold-down
comprising: a handle; a polymeric film having a first and second
side, at least a portion of said first side of said polymeric film
being coated with an adhesive layer; said handle being adhered to
said second side of said polymeric film, the continuity of contact
between said handle and the underlying second surface of said
polymeric film being interrupted at least in the vicinity of at
least a portion of the edge of said handle.
2. The device of claim 1 in which said continuity is interrupted to
such an extent that the contact area between said handle and said
polymeric film is reduced by from about 10% to about 70%.
3. The device of claim 1 in which said continuity is interrupted to
such an extent that the contact area between said handle and said
polymeric film is reduced by from about 10% to about 50%.
4. The device of claim 1 in which said continuity is interrupted to
such an extent that the contact area between said handle and said
polymeric film is reduced by from about 10% to about 30%.
5. The device of claim 2 in which said continuity is interrupted by
said handle being textured.
6. The device of claim 5 in which said texturing is accomplished by
piercing said handle.
7. The device of claim 6 in which said piercing is conducted by
piercing slots through said handle.
8. The device of claim 7 in which said slots are oriented
diagonally relative to the edge of said handle.
9. The device of claim 7 in which said slots are oriented generally
parallel to the edge of said handle.
10. The device of claim 6 in which said piercing is conducted by
piercing pinholes through said handle.
11. The device of claim 5 in which said texturing comprises said
handle being knurled.
12. The device of claim 5 in which said texturing comprises said
handle being embossed or debossed.
13. The device of claim 5 in which texturing comprises said first
adhesive coating being printed in a pattern on said first side of
said handle.
14. The device of claim 5 in which said texturing comprises said
handle being made of a material having a relatively rough first
surface facing said polymeric film.
15. The device of claim 2 in which said interruption of the
continuity of contact between said handle and said polymeric film
is accomplished by said second side of said polymeric film being
textured.
16. The device of claim 2 in which said interruption of the
continuity of contact between said handle and said polymeric film
is accomplished by said handle being pierced with slots, said slots
being generally diagonally relative to the perimeter of said
handle.
17. The device of claim 2 in which said interruption of the
continuity of contact between said handle and said polymeric film
is accomplished by said handle being pierced with slots, said slots
being generally parallel relative to the perimeter of said
handle.
18. The device of claim 1 in which said handle is adhered to said
polymeric film by an adhesive layer adhered to the underside of
said handle.
19. The device of claim 18 in which said continuity is interrupted
to such an extent that the contact area between said handle and
said polymeric film is reduced by from about 10% to about 30%.
20. The device of claim 1 in which said handle is adhered to said
polymeric film by electrostatic attraction.
21. The device of claim 20 in which said handle comprises a
conductive layer affixed to a non-conductive layer.
22. The device of claim 21 in which said continuity is interrupted
to such an extent that the contact area between said handle and
said polymeric film is reduced by from about 10% to about 30%.
23. A wound dressing, ingredient delivery device or IV hold-down
comprising: a handle; a polymeric film having a first and second
side, at least a portion of said first side of said polymeric film
being coated with an adhesive layer; said handle being adhered to
said second side of said polymeric film; an anti-static ingredient
being incorporated into one of said adhesive layer on said first
side of said polymeric film, or into an anti-static coating on
either said first or second surface of said polymeric film.
24. The device of claim 23 in which said anti-static ingredient is
incorporated into said adhesive layer on said first side of said
polymeric film.
25. The device of claim 24 in which said handle is adhered to said
polymeric film by an adhesive layer adhered to the underside of
said handle.
26. The device of claim 24 in which said handle is adhered to said
polymeric film by electrostatic attraction.
27. The device of claim 26 in which said handle comprises a
conductive layer affixed to a non-conductive layer.
28. A wound dressing, ingredient delivery device or IV hold-down
comprising: a handle; a polymeric film including a first and second
side; at least a portion of the first side of said polymeric film
being coated with an adhesive layer; said handle being adhered to
said second side of said polymeric film; said handle including a
thumb tab projecting away from an edge of said handle, said thumb
tab having a leading edge extending away from said handle at an
angle greater than 90.degree. with respect to the edge of said
handle in the direction in which the handle is lifted and pulled
when peeling said handle away from said polymeric film.
29. The device of claim 28 in which said angle is between about
120.degree. and about 150.degree..
30. The device of claim 29 in which said angle is about
135.degree..
31. The device of claim 28 in which said handle is configured in
the shape of a frame, such that it has an exterior perimeter edge
and an interior perimeter edge, said interior perimeter edge
defining an opening in said handle; said handle frame including a
diagonal cut extending between said inner and outer perimeter edges
of said handle, generally in alignment with said leading edge of
said thumb tab.
32. The device of claim 31 in which said diagonal cut and said
leading edge of said thumb tab are oriented at an angle of between
about 120 and about 150.degree. relative to said edge of said
handle in the direction in which said handle is to be pulled and
lifted away from said polymeric film.
33. The device of claim 31 in which said diagonal cut and said
leading edge of said thumb tab are oriented at an angle of about
135.degree. relative to said edge of said handle in the direction
in which said handle is to be pulled and lifted away from said
polymeric film.
34. The device of claim 31 in which said thumb tab projects
inwardly from said interior edge of said handle.
35. The device of claim 34 in which said diagonal cut and said
leading edge of said thumb tab are oriented at an angle of between
about 120 and about 150.degree. relative to said edge of said
handle in the direction in which said handle is to be pulled and
lifted away from said polymeric film.
36. The device of claim 34 in which said diagonal cut and said
leading edge of said thumb tab are oriented at an angle of about
135.degree. relative to said edge of said handle in the direction
in which said handle is to be pulled and lifted away from said
polymeric film.
37. The device of claim 34 in which said handle is adhered to said
polymeric film by an adhesive layer adhered to the underside of
said handle, there being no adhesive adhering said thumb tab to
said polymeric film.
38. The device of claim 34 in which said handle is adhered to said
polymeric film by electrostatic attraction.
39. The device of claim 38 in which said handle comprises a
conductive layer affixed to a non-conductive layer.
40. The device of claim 29 in which said handle is adhered to said
polymeric film by an adhesive layer adhered to the underside of
said handle; there being no adhesive adhering said thumb tab to
said polymeric film.
41. The device of claim 29 in which said handle is adhered to said
polymeric film by electrostatic attraction.
42. The device of claim 41 in which said handle comprises a
conductive layer affixed to a non-conductive layer.
43. A wound dressing, ingredient delivery device or IV hold-down
comprising: a handle having a periphery; a polymeric film layer
including a first side, a second side and a periphery; an adhesive
layer coating at least a portion of said first side of said
polymeric film layer, said handle being adhered to said second side
of the polymeric film layer; wherein a portion of the periphery of
said handle does not extend to said periphery of said polymeric
film layer.
44. The device according to claim 43 wherein: the periphery of said
handle is fashioned in a repeating pattern with only a portion of
each repeated pattern extending to said periphery of said polymeric
film layer.
45. The device according to claim 44 wherein: the shape of said
repeating pattern is scalloped.
46. The device according to claim 44 wherein: at least a continuous
substantial portion of at least one of a plurality of sides of the
periphery of said handle does not extend to the periphery of said
polymeric film layer.
47. The device of claim 46 in which said continuous substantial
edge portion is centrally located between the ends of said side
such that the end portions of said side extend to said periphery of
said polymeric film to give stability to the corners thereof.
48. The device according to claim 46 wherein: said handle further
includes a central opening.
49. The device according to claim 43 wherein at least a continuous,
substantial portion of at least two opposite sides of the periphery
of said handle does not extend to the periphery of the
corresponding opposite sides of said polymeric film layer.
50. The device of claim 49 in which said continuous substantial
edge portions are centrally located between the ends of said
opposite sides such that the end portions of said sides extend to
said periphery of said polymeric film to give stability to the
corners thereof.
51. The device according to claim 50 wherein: said handle further
includes a central opening.
52. The device of claim 47 in which said handle is adhered to said
polymeric film by an adhesive layer adhered to the underside of
said handle.
53. The device of claim 47 in which said handle is adhered to said
polymeric film by electrostatic attraction.
54. The device of claim 53 in which said handle comprises a
conductive layer affixed to a non-conductive layer.
55. The device of claim 43 in which said handle is adhered to said
polymeric film by an adhesive layer adhered to the underside of
said handle.
56. The device of claim 43 in which said handle is adhered to said
polymeric film by electrostatic attraction.
57. The device of claim 56 in which said handle comprises a
conductive layer affixed to a non-conductive layer.
58. A wound dressing, ingredient delivery device or IV hold-down
comprising: a handle having a first side and a periphery; a first
adhesive layer coating at least a portion of said first side of
said handle; a polymeric film layer including a first side, a
second side and a periphery; a second adhesive layer coating at
least a portion of said first side of said polymeric film layer,
said handle being adhered to said second side of said polymeric
film layer by said first adhesive layer; wherein said periphery of
said handle extends at least to said periphery of said polymeric
film, but said first adhesive layer is configured such that at
least a portion of said first adhesive layer does not extend to
said periphery of said underlying polymeric film.
59. The device according to claim 58 wherein: the periphery of said
adhesive layer is fashioned in a repeating pattern, with only a
portion of each repeated pattern extending to said periphery of
said underlying polymeric film.
60. The device according to claim 59 wherein: the shape of said
repeating pattern is scalloped.
61. The device according to claim 59 in which at least a continuous
substantial portion of said periphery of said adhesive layer does
not extend to said periphery of said underlying periphery of said
polymeric film.
62. The device of claim 61 in which said continuous substantial
edge portion is centrally located between the ends of said side
such that the end portions of said side extend to said periphery of
said polymeric film to give stability to the corners thereof.
63. The device according to claim 62 wherein: said handle further
includes a central opening.
64. A wound dressing, ingredient delivery device or IV hold-down
comprising: a handle; a polymeric film having a first and second
side, at least a portion of said first side of said polymeric film
being coated with an adhesive layer; said handle being adhered to
said second side of said polymeric film, means on said polymeric
film for minimizing the localized electrostatic charge buildup as
said handle is peeled away from said film when it is applied to a
patient's skin or mucosa, thereby minimizing edge release of said
polymeric film from said patient's skin or mucosa.
65. A method of minimizing edge release in wound dressings,
ingredient delivery devices and IV hold-downs which incorporate a
handle member to assist in their application, wherein the removal
of said handle member after application tends to lift the edge of
the adhesive coated polymeric film of the dressing or device away
from the skin or mucosa of the patient, said method comprising:
providing a handle; providing a polymeric film including a first
and a second side; coating at least a portion of the first side of
the polymeric film with an adhesive layer, said handle being
adhered to said second side of the polymeric film; and minimizing
the localized electrostatic charge buildup on said polymeric film
as the handle is peeled away from applied film, thereby minimizing
edge release of said film from the patient's skin or mucosa.
66. A method of minimizing edge release in wound dressings,
ingredient delivery devices and IV hold-downs which incorporate a
handle member to assist in their application, wherein the removal
of said handle member after application tends to lift the edge of
the adhesive coated polymeric film of the dressing or device away
from the skin or mucosa of the patient, said method comprising:
providing a handle; providing a polymeric film including a first
and second side; coating at least a portion of the first side of
said polymeric film with an adhesive layer; said handle being
adhered to said second side of said polymeric film; and
interrupting the continuity of contact between said handle and said
polymeric film, thereby minimizing edge release of said film from
the patient's skin or mucosa.
67. A method of minimizing edge release in wound dressings,
ingredient delivery devices and IV hold-downs which incorporate a
handle member to assist in their application, wherein the removal
of said handle member after application tends to lift the edge of
the adhesive coated polymeric film of the dressing or device away
from the skin or mucosa of the patient, said method comprising:
providing a handle having a first side; coating at least a portion
of the first side of said handle with a first adhesive layer;
providing a polymeric film including a first and second side;
coating at least a portion of the first side of said polymeric film
with a second adhesive layer; said handle being adhered to said
second side of said polymeric film by said first adhesive layer;
and reducing the area of contact between said first adhesive
coating and said polymeric film by from about 10 to about 70%.
68. A method of minimizing edge release in wound dressings,
ingredient delivery devices and IV hold-downs which incorporate a
handle member to assist in their application, wherein the removal
of said handle member after application tends to lift the edge of
the adhesive coated polymeric film of the dressing or device away
from the skin or mucosa of the patient, said method comprising:
providing a handle; providing a polymeric film including a first
and second side; coating at least a portion of the first side of
said polymeric film with a second adhesive layer; said handle being
adhered to said second side of said polymeric film; and providing
said handle with a thumb tab projecting away from an edge of said
handle at an angle greater than 90.degree. with respect to the edge
of said handle in the direction in which the handle is lifted and
pulled in a peeling away motion for peeling said handle away from
said polymeric film.
69. A method of minimizing edge release in wound dressings,
ingredient delivery devices and IV hold-downs which incorporate a
handle layer to assist in their application, wherein the removal of
the handle layer, after application of the device to the patient,
initiates the edge release, said method comprising: providing a
handle having a periphery; providing a polymeric film layer
including a first side, a second side and a periphery; applying an
adhesive layer to at least a portion of said first side of the
polymeric film layer; said handle being adhered to said second side
of the polymeric film layer; configuring said handle such that only
a portion of the periphery of said handle extends to the periphery
of the polymeric film layer, leaving a portion of said periphery of
said handle recessed away from said periphery of said polymeric
film layer.
70. A method of minimizing edge release in wound dressings,
ingredient delivery devices and IV hold-downs which incorporate a
handle layer to assist in their application, wherein the removal of
the handle layer, after application of the device to the patient,
initiates the edge release, said method comprising: providing a
handle having a first side and a periphery; applying a first
adhesive layer on at least a portion of said first side of said
handle, said adhesive layer having a periphery; providing a
polymeric film layer including a first side, a second side and a
periphery; applying a second adhesive layer to at least a portion
of said first side of said polymeric film layer; said handle being
adhered to said second side of said polymeric film layer by said
first adhesive layer; said periphery of said handle extending at
least to said periphery of said polymeric film; and configuring
said first adhesive layer such that only a portion of the periphery
of said first adhesive layer extends to the periphery of said
underlying polymeric film layer.
Description
CLAIM OF PRIORITY
[0001] Applicant claims priority to provisional application Ser.
No. 60/484,711, filed Jul. 3, 2003, provisional patent application
Ser. No. 60/508,088, filed Oct. 2, 2003, and provisional patent
application Ser. No. 60/570,666, filed May 13, 2004.
BACKGROUND OF THE INVENTION
[0002] The present invention relates to adhesive devices used as
wound dressings, ingredient delivery devices and IV hold-downs.
[0003] Wound dressing and IV hold-downs in particular comprise a
layer of polymeric film having an adhesive layer on one side
thereof, which is protected during storage and handling by a
release liner. United States Patent Publication 2002/0107466 A1
discloses such devices which also have a handling member adhered to
the non-adhesive coated side of the polymeric film by means of a
pressure sensitive adhesive. The pressure sensitive adhesive used
between the handle and the polymeric film is less aggressive than
the pressure sensitive adhesive used on the underside of the
polymeric film, such that once the polymeric film is applied to a
patient's skin or mucosa, the handle can be peeled away without
peeling the polymeric film away from the patient's skin.
[0004] Experience has shown that regardless of differences in
adhesive strength between the skin or mucosa adhesive and the
handle adhesive, there is a tendency for the edge of the polymeric
film to lift away from the user's skin or mucosa when the handle
member is peeled away from the back of the polymeric film. This
same tendency is observed in the wound dressing disclosed in U.S.
Pat. No. 6,169,224, where the handling member is sealed to the
polymeric film by a heat activated adhesive.
SUMMARY OF THE INVENTION
[0005] In the various aspects of the present invention, inadvertent
edge release caused by peeling the handle member away from the
polymeric film can be minimized by the following methods or
combinations thereof: [0006] 1. minimizing the electrostatic charge
buildup in the localized area of the polymeric film beneath the
handle, as the handle is peeled away from the film; and/or [0007]
2. decreasing the mechanical advantage of the handle relative to
the thin film. [0008] In various different preferred aspects of the
invention, either or both of these are accomplished by: [0009] 1.
interrupting the continuity of contact between the handle and the
underlying surface of the polymeric film to which the handle is
adhered, said adherence either being due to electrostatic
attraction or to the use of an adhesive layer on the underside of
the handle; [0010] 2. placing an anti-static ingredient in one of,
the adhesive coating on the underside of the polymeric film, or in
an anti-static coating on the upper or lower surface of the
polymeric film itself, with the anti-static agent preferably being
located in an adhesive layer on the underside of the polymeric
film; [0011] 3. removing at least a portion of the periphery of the
handle layer, or of the adhesive layer on the underside of the
handle if one issued, so that it does not extend to the periphery
of the polymeric film layer upon which the handle layer resides;
and/or [0012] 4. reducing the surface area of the adhesive coating
disposed on the periphery of handle.
[0013] In another aspect of the invention, an inwardly-directed
thumb tab, oriented at an obtuse angle with respect to the edge of
the handle in the direction in which the handle is pulled, is
provided to facilitate peeling of the handle away from the
polymeric film. Such a thumb tab enhances the ease with which the
handle is peeled away from the polymeric film. The thumb tab starts
the peeling at such an angle that the tendency of the handle to
lift the underlying polymeric film away from the patient's skin or
mucosa is minimized.
[0014] These and other objects, features and advantages of the
invention will be more fully understood and appreciated by
reference to the written specification and appended drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1 is a plan view of a wound dressing, ingredient
delivery device, or IV hold-down in accordance with a first
embodiment of the present invention;
[0016] FIG. 2 is a cross sectional view of the wound dressing,
ingredient delivery device, or IV hold-down of FIG. 1, taken along
line II-II of FIG. 1;
[0017] FIG. 3 is a perspective view of a wound dressing, ingredient
delivery device, or IV hold-down of FIG. 1, with the handle being
removed;
[0018] FIG. 4 is an enlarged sectional view of a wound dressing,
ingredient delivery device, or IV hold-down of FIG. 2, taken at
section IV of FIG. 2 with the release liner removed;
[0019] FIG. 5 is a plan view of a wound dressing, ingredient
delivery device, or IV hold-down in accordance with a second
embodiment of the present invention;
[0020] FIG. 6 is a cross sectional view of a wound dressing,
ingredient delivery device, or IV hold-down of FIG. 5, taken along
line VI-VI, with the release liner removed;
[0021] FIG. 7 is a plan view of a wound dressing, ingredient
delivery device, or IV hold-down in accordance with a third
embodiment of the present invention.
[0022] FIG. 8 is a cross sectional view of a wound dressing,
ingredient delivery device, or IV hold-down of FIG. 7, taken along
line VII-VII of FIG. 7;
[0023] FIG. 9 is a plan view of a wound dressing, ingredient
delivery device, or IV hold-down in accordance with a fourth
embodiment of the present invention.
[0024] FIG. 10 is a cross sectional view of a wound dressing,
ingredient delivery device, or IV hold-down of FIG. 9, taken along
line X-X of FIG. 9;
[0025] FIG. 11 is a cross sectional view of a wound dressing,
ingredient delivery device, or IV hold-down in accordance with a
fifth embodiment of the present invention;
[0026] FIG. 12 is a cross sectional view of a wound dressing,
ingredient delivery device, or IV hold-down in accordance with a
sixth embodiment of the present invention;
[0027] FIG. 13 is a cross sectional view of a wound dressing,
ingredient delivery device, or IV hold-down in accordance with a
seventh embodiment of the present invention;
[0028] FIG. 14 is a cross sectional of a wound dressing, ingredient
delivery device, or IV hold-down in accordance with an eighth
embodiment of the present invention;
[0029] FIG. 15 is a plan view of a wound dressing, ingredient
delivery device, or IV hold-down of FIG. 14;
[0030] FIG. 16 is a plan view of a wound dressing, ingredient
delivery device, or IV hold-down;
[0031] FIG. 17 is a cross sectional view of the wound dressing,
ingredient delivery device, or IV hold-down of FIG. 16, taken along
line XVII-XVII of FIG. 16;
[0032] FIG. 18 is a plan view of a wound dressing, ingredient
delivery device, or IV hold-down in accordance with a tenth
embodiment of the present invention; and
[0033] FIG. 19 is a plan view of a wound dressing, ingredient
delivery device, or IV hold-down in accordance with an eleventh
embodiment of the present invention.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENT
Introduction
[0034] The term "dressing" as used herein is to be understood to
include wound dressings, IV hold-downs and transdermal, dermal,
transmucosal and mucosal delivery systems. The various preferred
embodiments disclosed herein have many components or similar
components in common, which are described in this Introduction
using numbers which are common to all embodiments. The differing
embodiments, and the similar elements thereof, are distinguished by
adding the letters a-j.
[0035] In the various preferred embodiments, the basic elements of
a device in accordance with the present invention comprise a handle
10 having either an adhesive coating 20 on the undersurface thereof
or being electrostatically adhered to an underlying polymeric film
30, and preferably having an inwardly-projecting thumb tab 11
(FIGS. 1-3). Handle 10 is applied to the non-adhesive coated
surface of a polymeric film 30 having a pressure sensitive adhesive
layer 40 on the undersurface thereof. Adhesive layer 40 is
protected during handling and storage by a release liner 50 having
a silicone coating layer 51. In use, release liner 50 is removed
from the assembled polymeric film 30 and handle 10, and handle 10
is then used to manipulate the polymeric film and place it on the
patient. Once the polymeric film as been applied to the patient,
the user grasps inwardly-projecting thumb tab 11 on handle 10 and
peels handle 10 away from the applied polymeric film 30.
[0036] Inadvertent edge release caused by removal of the handle 10
is minimized by any one or any combination of the following: [0037]
1. the angle at which thumb tab 11 projects from handle 10; [0038]
2. by minimizing the build up of localized electrostatic charge on
the polyurethane film as the handle is removed; and/or [0039] 3.
decreasing the mechanical advantage of handle 10 relative to film
30.
[0040] Objects 2 and 3 are accomplished by any one or any
combination of the following: [0041] 1. interrupting the continuity
of contact between the handle and the underlying non-adhesively
coated surface of the polymeric film; [0042] 2. placing an
anti-static ingredient in one of, the adhesive coating on the
underside of the polymeric film, or in an anti-static coating on
the upper or lower surface of the polymeric film itself, with the
anti-static agent preferably being located in the adhesive layer on
the underside of the polymeric film; [0043] 3. removing at least a
portion of the periphery of the handle layer, or of the adhesive
layer on the underside of the handle, if one issued, so that it
does not extend to the periphery of the polymeric film layer upon
which the handle layer resides; and/or [0044] 4. reducing the
surface area of the adhesive coating disposed on the periphery of
handle.
[0045] Handle 10 is preferably made of a stiffer and generally
thicker material than that of polymeric film 30. Typical of such
materials are plastic or paper material. Useable plastics include
polyesters, polycarbonates, PVC's, polyurethanes, polyethylene
vinyl acetates, polyester copolymers, polyethylenes, and
polypropylenes. In the preferred embodiment a silicone coated paper
50, with a silicone coating 51 on the upper surface thereof, is
used.
[0046] In FIG. 2, the undersurface of each handle 10 is coated with
an optional adhesive layer 20, preferably a pressure sensitive
adhesive which is moderately aggressive with respect to polymeric
film 30, but which does not adhere or adheres less aggressively to
either the silicone coating 51 on release liner 50 or to human
skin. In this way, a user can readily fold back an end portion of
release liner 50 to expose an end of handle 10, and the exposed end
can then be used to peel film 30 away from release liner 50. The
adhesive of layer 20 is "moderately aggressive" in that handle 10
remains attached to polymeric film 30 when it is peeled away from
release liner 50, and while it is being handled and applied to the
patient's skin. However, adhesive 20 is less aggressive with
respect to its adhesion to polymeric film 30, than is the adhesion
of layer 40 on the undersurface of polymeric film 30 toward human
skin or mucosa. As a result, handle 10 can be peeled away from
polymeric film 30, once film 30 is applied to the patient.
[0047] One type of adhesive which we have found useful for layer 20
on the undersurface of handle 10 is a low tack removable
acrylate-based adhesive with a peel adhesive level of approximately
three ounces. Other useful adhesives include, but are not limited
to, silicone, urethane, synthetic rubber and natural rubber.
Adhesives of this type can be formulated to have essentially no or
very little adhesion to the human skin or to the silicone coating
51 on the release liner 50, but still adhere firmly but releasably
to film 30.
[0048] Alternatively, handle 10 can be electrostatically adhered to
polymeric film 30, rather than through the use of an adhesive layer
on the undersurface of handle 10. In such an embodiment, handle
layers 10 and 20 as shown in the drawings comprise a layer of
non-conductive material 10, e.g., a layer of polymeric film, and a
layer of conductive material 20 (rather than a layer of adhesive).
For example, a layer of aluminum 20 might be vapor deposited onto
non-conductive polymeric film layer 10.
[0049] Optionally, conductive layer 20 may be disposed between two
layers of non-conductive polymeric films, rather than having a
single layer on only one side. However, only one non-conductive
layer 20 is required, and handle 10-20 can be applied to polymeric
film 30 with either conductive layer 20 applied directly against
film 30, or with non-conductive layer 10 lying against film 30. The
static change generated during handling of the materials in
manufacture is sufficient to electrostatically bond handle 10-20 to
film 30. An optional corona treatment may be used as a way to
increase the electrostatic surface adhesion of the polymeric film,
but it is not necessary.
[0050] A second electrostatic charge is created during the
application process which enhances the electrostatic bond between
handle 10-20 to polymeric film 30. This second electrostatic charge
is generated when release liner 50 is peeled away from the adhesive
layer 40 on the undersurface of film 30. Though not wishing to be
bound by theory, when these two materials are separated, a positive
charge will accumulate on the surface of the polyurethane and a
negative charge on the release liner. Since two oppositely charged
surfaces will attract each other, the positive static charge of
polymeric film 30 is then attracted to the electron rich,
negatively charged, conductive material 20. Therefore, this
additional statically attractive force adds to the retention of
handle 10-20 to polymeric film 30, and tends to remain until the
user applies the system to the patient, at which time the system is
grounded, thereby removing or at least diminishing the
electrostatic attractive force.
[0051] Polymeric film 30 is preferably comprised of any breathable
and waterproof material. In the preferred embodiment, a polymeric
film on the order of from about 0.5 to about 4 mils (0.0005 to
0.004 inches) is preferred. The film is preferably very flexible,
allowing it to conform readily to the user's skin or mucosa. The
film must have sufficient strength to afford resistance to damage
in handling and in use. It also preferably allows the passage of
oxygen, thereby allowing the skin or mucosa to breathe. The
polymeric film material preferably is a polyurethane film such as a
Pebax.RTM. film (MediFilm 810, 2 mils, Mylan). Additionally,
copolymers of polyethylene and vinyl acetate are also
preferable.
[0052] The adhesive layer 40 may be any adhesive that bonds well to
skin or mucosa. Preferably, a pressure sensitive adhesive is used.
A type of adhesive found useful for adhesive layer 40 is a
permanent acrylate-based pressure sensitive adhesive designed for
skin, with a peel adhesion level of approximately 50 ounces. Other
useful adhesives include, but are not limited to, silicone,
urethane, synthetic rubber and natural rubber. Such adhesives can
be formulated to adhere releasably to the silicone coated surface
51 of a release liner 50. At the same time, they can be formulated
to adhere firmly to the patient's skin or mucosa such that
polymeric film 30 will not peel away unless someone intends to do
so. For example, one can use an acrylate derivative adhesive such
as copolymers of alkyl acrylate/vinyl acetate containing --OH
or/and --COOH functional groups, or hydrophobic styrenic rubber
polymer or PIB containing 1 to 20% hydroattractants such as PVP,
PVA, and cellulose derivatives such as Duro-Tak 87-2516 (National
Starch), and PIB containing 20% Kollidong.RTM. CL-M (BASF).
[0053] The entire assembly of handle 10, adhesive layer 20,
polymeric film 30 and adhesive layer 40 is releasably adhered to a
release liner 50. Release liner 50 may be comprised of any material
that will releasably adhere adhesive layer 40. However, in the
preferred embodiment, release liner 50 is a paper material with a
silicone coating 51 on the top surface thereof.
[0054] The very properties of polymeric film 30 which make it
desirable in use make it difficult to handle in application. The
drape and flexibility properties of polymeric film 30 may cause it
to fold over onto itself and self-adhere relatively easily when one
is trying to apply the system to the user's skin. The thicker
handle 10 disclosed in the preferred embodiment reduces these
shortcomings and makes the systems relatively easy to apply without
fouling polymeric film 30. However, the structural characteristics
of the stiffer and generally thicker material of handle 10 which
aid in the application is compromised when a cut line 13 is made to
handle 10 (FIG. 1). Cut line 13, which aids the applicator in the
removal of handle 10, compromises the structural integrity of
handle 10 and allows the polymeric film 30 to fold over and adhere
to itself.
[0055] Edge release typically occurs with these systems when handle
10 is removed from polymeric film layer 30. The generally thicker
material of handle 10 creates a lever arm out of handle 10 when
handle 10 is being peeled off of film 30. This lever arm created by
handle 10 acts to pry up film 30 from the patient's skin. If this
force is great enough the edge of film 30 can separate from the
patient's skin (e.g., edge release occurs). In general, as the
stiffness of the material of handle 10 increases, the less flexible
it becomes. The less flexible the handle becomes, the longer the
lever arm becomes and this in turn creates higher forces which act
upon film layer 30 causing more significant edge release. In
addition, it is believed that as handle 10 is removed from
polymeric film layer 30, it causes an electrostatic buildup in film
layer 30, which contributes to the tendency of the edge of film 30
to release from and be pulled away from a patient's skin or mucosa.
Therefore, the properties that make handle 30 useful, namely its
stiffness, also create edge release.
The Angled Thumb Tab
[0056] Tab 11 is provided on handle 10 to minimize the tendency of
film 30 to fold over at cut line 13, as well as aid in the removal
of handle 10. Inwardly-projecting thumb tab 11 includes a distal
portion 12. Preferably, the underside of thumb tab 11 is not coated
with adhesive. In the preferred embodiment, the leading edge A of
thumb tab 11 is disposed at an angle greater than 90 degrees with
respect to the edge of the handle in the direction "B" in which the
handle is pulled, and distal portion 12 extends beyond cut line 13
into window 15 of handle 10. Preferably, the angle is between about
120.degree. and about 150.degree., and most preferably about
135.degree.. This placement of distal portion 12 provides more
support for polymeric film 30 and handle 10 and it is therefore
less likely that polymeric film 30 will fold at cut line 13.
However, this is merely the preferred embodiment and tab 10 may
also be disposed outwardly. Similarly, it is preferably that cut
line 13 extends between the edges of handle 10 at between about
130.degree. and about 150.degree., most preferably about
135.degree., with respect to the direction in which handle 10 will
be initially peeled away from film 30. This also helps prevent film
30 from buckling across the cut through the handle.
[0057] As described above, edge release typically occurs with these
systems when handle 10 is removed from polymeric film layer 30. Tab
11 minimizes this tendency by reducing the mechanical advantage
that handle 10 has over polymeric film 30 when handle 10 is being
peeled off. The mechanical advantage is reduced by the angle at
which thumb tab 11 projects from handle 10 and subsequently, the
angle at which handle 10 is removed from polymeric film 30.
Interrupting the Continuity of Contact Between the, Handle and the
Polymeric Film
[0058] In addition to the mechanical advantages of thumb tab 11,
edge release can also be minimized by interrupting the continuity
of contact between the adhesive coated surface of handle 10 and the
underlying non-adhesively coated surface of the polymeric film 30,
at least in the vicinity of at least a portion of the edge of
handle 10. Although not wishing to be bound by theory, it is
believed that this interruption helps to minimize edge release in
three ways: [0059] 1. less contact area means handle 10 can be
removed more easily; [0060] 2. the mechanical advantage of the
handle relative to the film 30 edge is reduced; and [0061] 3.
localized electrostatic build up when handle 10 is peeled away from
film 30 is reduced.
[0062] Interrupting the contact between the adhesive layer 20 of
handle 10 and film 30 reduces the contact area. We have found it
helpful to reduce the contact area by from about 10% to about 70%,
preferably about 10% to about 50%, and most preferably from about
10% to about 30%, as compared to the contact area without such
interruptions in continuity. If a greater reduction in contact area
is desired, a more aggressive adhesive can be used in adhesive
layer 20.
[0063] One technique for interrupting the adhesive layer of the
handle and the non-adhesively coated surface of polymeric film 30
is to texture handle 10, at least at adhesive layer 20 on handle 10
which faces and is adhered to polymeric film 30. Preferably, this
texturing is done by piercing slots 16 through handle 10 and
adhesive coating layer 20 (FIGS. 1-6). Other techniques include
placing pin holes through handle 10 (FIGS. 7, 8); knurling handle
10 (FIGS. 9, 10); embossing or debossing handle 10; printing
adhesive layer 20 in a pattern (FIG. 11); and employing a handle
material having a relatively rough surface facing polymeric film
layer 30. Alternatively, the polymeric film 30 may be textured on
the side facing handle 10 (FIG. 12). Preferably, the texturing is
done in such a way as to break the adhesive coating layer itself,
as distinguished from merely making it irregular in shape (see
e.g., FIGS. 2, 4 and 8).
[0064] As depicted in FIG. 1, a first embodiment is shown utilizing
a plurality of piercing slots 16 completely surrounding and
angularly disposed with respect to window 15. The slots 16 may be
pierced from the either side. However, in the preferred embodiment
the slots are pierced from the top surface and through adhesive
layer 20 on handle 10 as shown in FIG. 2.
[0065] In response to the piercing action, material of handle 10 at
the pierced location is deflected toward polymeric film layer 30
resulting in a raised portion 17 of slot 16 (FIG. 2). Film 30 tends
to bridge over raised portions 17 of slots 16, creating a "tunnel"
at which film 30 is separated from handle 10. Raised portion 17
thereby effectively reduces the area of contact between film 30 and
adhesive layer 20 of handle 10. This reduces the adhesive retention
of handle 10 to polymeric film 30.
[0066] Also when handle 10 is removed from polymeric film 30 an
atmospheric venting effect 21 occurs in the tunneling area (FIG.
4). This venting effect enhances the ease of removal of the handle.
The result is less inadvertent edge release.
[0067] Additionally, raised portion 17 which is in contact with
polymeric film 30 provides a conductive pathway between polymeric
film 30 and handle 10. This pathway interrupts the continuity of
contact between the adhesive coated surface 20 of handle 10 and the
underlying non-adhesively coated surface of polymeric film 30
thereby minimizing the electrostatic buildup of localized
electrostatic charge on the polyurethane film during the removal of
handle 10. This minimization of electrostatic build up contributes
towards the reduction in edge release.
[0068] FIG. 5 shows a second embodiment including slots 16a which
are parallel to window 15a along its sides, and angularly disposed
with respect to the top and bottom surface. In this configuration,
after the release liner 50a is removed, atmospheric venting effect
21a again occurs (FIG. 6).
[0069] A third embodiment is shown in FIG. 7 and is similar to the
first two embodiments except that it utilizes a puncture or pinhole
to interrupt the continuity between the handle 10b and the
polymeric film 30b. As shown in FIG. 8, pinholes 16b minimize edge
release by reducing the adhesion of handle 10b to the polymeric
film 30b and also providing a conductive pathway between polymeric
film 30 and handle 10 in order to minimize electrostatic buildup as
described above.
[0070] A fourth embodiment using a knurled pattern is depicted in
FIG. 9. The knurled pattern may take any geometrical shape and be
either embossed or debossed on handle 10c. Additionally, the
pattern may be varied thereby increasing or decreasing the contact
area to accommodate the application requirements. Unique to this
embodiment is the feature that the knurls 16c do not puncture
handle 10c. Instead, the reduction in adhesion is accomplished
through the bottom of knurls 16c residing directly on polymeric
film layer 30c and therefore reducing the adhesive contact surface
of polymeric film 30c, as shown if FIG. 10. However, this is not
meant to be limiting and knurls 16c may puncture handle 10c if
required. Embossing or debossing handles 10 is similar to knurling,
though the raised portion would probably be larger in area than the
knurl projections.
[0071] Additionally, a fifth embodiment is shown in FIG. 11. This
embodiment reduces the adhesion between handle 10d and polymeric
film layer 30d by patterning the adhesive layer. As described
above, the pattern may be varied thereby increasing or decreasing
the contact area according to the specific requirements of the
application.
[0072] Still further, it is possible to accomplish this reduction
in continuity through the use of a rough surface or handle 10,
facing polymeric film layer 30. This can be done, for example,
through the use of a rough or non-smooth paper for handle 10.
[0073] FIG. 12 shows a sixth embodiment which uses a polymeric film
layer 30e having at least a textured upper surface to reduce the
continuity of contact between handle 10e and polymeric film 30e.
The pattern may take any geometrical shape and be either embossed
or debossed on polymeric film layer 30e. Additionally, as described
above, the pattern may be varied thereby increasing or decreasing
the contact area to accommodate the application requirements. The
patterning of polymeric film layer 30e may be accomplished
mechanically or chemically.
[0074] While the embodiments described above are wound dressings or
IV hold-down devices, the various aspects of the present invention
are also applicable to devices designed to deliver active
ingredients to or through the dermal or mucosal layers. Such
delivery systems typically deliver the active via a gel modulated
system, membrane modulated system, or an adhesive modulated system.
All of the embodiments of FIGS. 1-19 can be made to be ingredient
delivery devices by incorporating an active ingredient into
adhesive layer 40-40j, for example.
[0075] The delivery system depicted in FIG. 14 includes a
breathable and waterproof polymeric film 30g. Layered to a first
side of film 30g is adhesive layer 40g. Adhered to adhesive layer
40g of film 30g is an active ingredient containing island 60g.
Island 60g comprises a thin or ultra thin polymeric backing film
62g. Layered to backing film 62g is an active ingredient layer 63g
that may or may not be incorporated into an adhesive.
Incorporating an Anti-Static Ingredient
[0076] Edge release can also be minimized by utilizing an
anti-static coating to minimize the electrostatic buildup that
occurs when handle 10 is removed. A seventh embodiment using an
anti-static coating 61 is shown in FIG. 13. The anti-static coating
layer 61 on polymeric film layer 30f acts to minimize the
electrostatic buildup of localized electrostatic charge on
polyurethane film 30f during the removal of the handle 10f. The
minimization of electrostatic build up contributes towards the
reduction in edge release.
[0077] Alternatively, or in addition, anti-static material may be
incorporated onto the lower surface of polyurethane film 30f or
into adhesive layer 40f of polyurethane film 30f.
Removing a Portion of Handle or Adhesive at the Periphery
[0078] Removing a portion of handle 10, or its underlying adhesive
layer 20, from over at least a portion of the edge area of film
layer 30 helps to minimize edge release. Although not wishing to be
bound by theory, it is believed that this is accomplished in three
ways: [0079] 1. less adhesive contact area means handle 10 can be
removed more easily; [0080] 2. reducing the ability of handle 10 to
act as a lifting lever relative to film 30, at least when a portion
of the handle per se is removed; and [0081] 3. minimizing the
localized electrostatic build up at the periphery of film 30 when
handle 10 is peeled from film 30, by moving the periphery of handle
10 away from the edge of film 30.
[0082] One way to move at least a portion of the edge of said
handle away from the periphery of said polymeric film is to pattern
the handle layer with a scalloped pattern as shown in FIGS. 16 and
17. In this embodiment, the scalloping extends around the entire
perimeter of handle 10. The scalloped edge reduces the mechanical
advantage of handle 10 primarily in two ways. The first is by
reducing the surface area of adhesive coating 20 disposed on the
periphery of handle 10, and the second is by reducing the ability
of handle 10 to act as a lever. In the first mode, a portion of the
periphery of handle 10 is removed resulting in scalloped edge 15.
Simultaneous to this removal of a portion of handle 10 is the
removal of a corresponding portion of adhesive coating 20 attached
thereto. This removal of adhesive 20 on the periphery of handle 10
reduces the upward force exerted on the periphery of polymeric film
30 by adhesive coating 20 during its removal. Reducing the upward
force exerted on the periphery of polymeric film 30 reduces edge
lift. In the second mode, scalloped edge 15 reduces the ability of
the generally thicker material of handle 10 to act as a lever
arm.
[0083] When the peripheral interaction between adhesive layer 20
and polymeric film 30 is removed, the localized electrostatic
buildup on film 30 is also reduced. This is because the interaction
between adhesive layer 20 and film layer 30, during their
separation, causes the electrostatic buildup. The removal of a
portion of the peripheral edge of handle 10, and subsequently
adhesive layer 20, or the removal of some of the adhesive at the
edges of handle 10 minimizes the electrostatic buildup on the
peripheral edge of polymeric film 30 by removing this interaction
and therefore, reduces edge lift.
[0084] The scalloped edge (15) of handle 10 is depicted in FIG. 16
as having a wave like or sinusoidal like pattern, leaving
projecting portions 16 extending to the edge of film layer 30.
Other geometrical forms may be used which reduce the interaction
between the periphery of handle 10 and the periphery of film 30.
While a handle could be made that simply does not extend to the
edge of film layer 30, thereby reducing edge lift, the scalloped
pattern has the advantage of having end portions 16 that extend to
the edge of film 30. End portions 16 act to support thin film 30
and keep it from folding over onto itself during application.
Therefore, scalloped edge 15 retains the benefits of a handle layer
(e.g., ease of application) while minimizing the negative effects
of a handle layer (e.g., edge lift).
[0085] In the FIG. 18 embodiment, the edge portion of handle 10
along two opposite sides thereof, preferably the longest sides,
have been substantially removed as a continuous, uninterrupted
strip. This leaves the longest edge portions 31 of polymeric film
but retains a portion of handle 10 along two other sides which
extends to the film periphery sides to support film 30 during
application. Preferably, only the central portion of the edge of
handle 10 is removed, such that end or corner portions 11 of handle
10 extend out to the edges or corners to give stability. The FIG.
19 embodiment is similar to the FIG. 18 version, but also
incorporates a window of removed handle material which is centrally
located on the dressing, leaving the central portion 32 of film 30
also exposed.
[0086] Although only a few preferred embodiments have been shown
and described it is envisioned that there are numerous geometrical
patterns that may used. Additionally, there are supplementary
methods which can be combined with the various edge geometries for
reducing the edge lift even further. For example, the preferred
embodiment may include additional features such as texturing handle
10, texturing adhesive layer 20, texturing polymeric film layer 30
and/or using an anti-static ingredient in one of, the adhesive
coating on the underside of the polymeric film, or on the upper or
lower surface of the polymeric film itself. Additionally, texturing
may be done by piercing slots, placing pin holes, knurling,
embossing or debossing, or creating a relatively rough surface on
handle 10.
CONCLUSION
[0087] The embodiments described above minimize the problem of edge
release which typically occurs in adhesive devices used as wound
dressings, ingredient delivery devices and IV hold-downs. Of course
it is understood that the above are preferred embodiments only, and
that various changes and alterations can be made without departing
from the spirit and scope of the invention as set forth in the
appended claims, as interpreted in accordance with the principles
of patent law.
* * * * *